If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Carbon Side Effects Reported to FDA

This is a report of a 76-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: laparoscopy, who was treated with Carbon Dioxide (dosage: Intraperitoneal, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pneumomediastinum, Subcutaneous Emphysema, Post Procedural Complication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Dioxide treatment in female patients, resulting in Pneumomediastinum side effect.

This report suggests a potential Carbon DioxideDysaesthesia side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: skin infection,off label use and used Carbon Dioxide (dosage: NA) starting NS. After starting Carbon Dioxide the patient began experiencing various side effects, including: Dysaesthesia, Muscle Contracture, Subcutaneous EmphysemaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Carbon Dioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dysaesthesia, may still occur.

This Pneumomediastinum problem was reported by a health professional from Country Not Specified. A 65-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: laparoscopic surgery. On NS this consumer started treatment with Carbon Dioxide (dosage: NA). The following drugs were being taken at the same time:

(metoclopramide)

(ondansetron)

(dexamethasone)

When using Carbon Dioxide, the patient experienced the following unwanted symptoms/side effects: Pneumomediastinum, Post Procedural Complication, Subcutaneous EmphysemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumomediastinum, may become evident only after a product is in use by the general population.

This is a report of a 37-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: laparoscopic surgery, who was treated with Carbon Dioxide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Crepitations, Subcutaneous Emphysema, Hypercapnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Dioxide treatment in female patients, resulting in Crepitations side effect.

Carbon Side Effect Report#9304884 Respiratory Acidosis

This report suggests a potential Carbon DioxideRespiratory Acidosis side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: laparoscopy and used Carbon Dioxide (dosage: NA) starting NS. After starting Carbon Dioxide the patient began experiencing various side effects, including: Respiratory AcidosisAdditional drugs used concurrently:

(isoflurane)

(fentanyl)

Although Carbon Dioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Acidosis, may still occur.

Carbon Side Effect Report#9274678 Intestinal Ischaemia

This Intestinal Ischaemia problem was reported by a consumer or non-health professional from GB. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pneumoperitoneum. On NS this consumer started treatment with Carbon Dioxide (dosage: Procedure Took 50 Minutes). The following drugs were being taken at the same time: NA. When using Carbon Dioxide, the patient experienced the following unwanted symptoms/side effects: Intestinal IschaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Intestinal Ischaemia, may become evident only after a product is in use by the general population.

This Traumatic Liver Injury side effect was reported by a consumer or non-health professional from AU. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: pneumoperitoneum.The patient was prescribed Carbon Dioxide (drug dosage: NA), which was initiated on

This is a report of a 68-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: pneumoperitoneum, who was treated with Carbon Dioxide (dosage: Preocedure Lasted For 85 Min, start time: NS), combined with:

Halotane

and developed a serious reaction and side effect(s): Intestinal Ischaemia, Renal Failure, Abdominal Sepsis, Intestinal Anastomosis Complication, Post Procedural Complication, Surgical Procedure Repeated, Ileal Gangrene, Colon Gangrene after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Dioxide treatment in male patients, resulting in Intestinal Ischaemia side effect. The patient was hospitalized.

This report suggests a potential Carbon DioxideSmall Intestine Gangrene side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pneumoperitoneum and used Carbon Dioxide (dosage: NA) starting NS. After starting Carbon Dioxide the patient began experiencing various side effects, including: Small Intestine Gangrene, Post Procedural ComplicationAdditional drugs used concurrently:

Isoflurane

Although Carbon Dioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Small Intestine Gangrene, may still occur.

This Necrosis Ischaemic problem was reported by a physician from US. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: laparoscopy. On NS this consumer started treatment with Carbon Dioxide (dosage: Less Than 75 Minutes). The following drugs were being taken at the same time:

Sevoflurane

Nitrous Oxide

When using Carbon Dioxide, the patient experienced the following unwanted symptoms/side effects: Necrosis Ischaemic, Acute Abdomen, Atrial Fibrillation, Hypotension, Abdominal Adhesions, Intestinal Perforation, Systemic Candida, Neuropathy Peripheral, PneumoniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Necrosis Ischaemic, may become evident only after a product is in use by the general population.

Carbon Side Effect Report#9240085 Air Embolism, Monoplegia

This Air Embolism side effect was reported by a consumer or non-health professional from US. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Carbon Dioxide (drug dosage: Total), which was initiated on NS. Concurrently used drugs:

(iodixanol) 50 Ml

.After starting to take Carbon Dioxide the consumer reported adverse symptoms, such as: Air Embolism, MonoplegiaThese side effects may potentially be related to Carbon Dioxide.

This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: angiogram, who was treated with Carbon Dioxide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Sensory Loss, Motor Dysfunction, Paralysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Dioxide treatment in male patients, resulting in Sensory Loss side effect. The patient was hospitalized.

This report suggests a potential Carbon DioxideAbdominal Pain Lower side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: angiogram and used Carbon Dioxide (dosage: NA) starting NS. After starting Carbon Dioxide the patient began experiencing various side effects, including: Abdominal Pain Lower, Post Procedural Complication, Vomiting, Colitis Ischaemic, Suprapubic Pain, White Blood Cell Count Increased, Shift To The Left, Computerised Tomogram AbnormalAdditional drugs used concurrently: NA. Although Carbon Dioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Lower, may still occur.

Carbon Side Effect Report#8354803-1Carbon Monoxide Poisoning

This Carbon Monoxide Poisoning problem was reported by a health professional from Belgium. A 87-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Carbon Monoxide (dosage: NA). The following drugs were being taken at the same time:

Duragesic-100 (2x100 Ug/hr + 4x50 Ug/hr Patches)

Zolpidem

When using Carbon Monoxide, the patient experienced the following unwanted symptoms/side effects: Carbon Monoxide PoisoningAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Carbon Monoxide Poisoning, may become evident only after a product is in use by the general population.

Carbon Side Effect Report#8316639-7Completed Suicide

This Completed Suicide side effect was reported by a physician from United States. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Carbon Black (drug dosage: Unk Ukn, Unk), which was initiated on NS. Concurrently used drugs:

Clozapine (Unk Ukn, Unk)

.After starting to take Carbon Black the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Carbon Black.

Carbon Side Effect Report#8065392-3Completed Suicide

This is a report of a 82-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Carbon Monoxide (dosage: NA, start time: NS), combined with:

Carbamazepine

Laxatives

Diazepam

and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Monoxide treatment in male patients, resulting in Completed Suicide side effect.

This report suggests a potential Carbon MonoxideCardiac Arrest side effect(s) that can have serious consequences. A 82-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Carbon Monoxide (dosage: (df Resipiratory (inhalation))) starting NS. After starting Carbon Monoxide the patient began experiencing various side effects, including: Cardiac Arrest, Completed Suicide, Respiratory Arrest, PoisoningAdditional drugs used concurrently:

Diazepam ((df))

Laxative (stimulant) ((df))

Carbamazepine ((df))

Although Carbon Monoxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.

This Completed Suicide problem was reported by a health professional from United States. A 49-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Carbon Monoxide (dosage: Unk, Unk). The following drugs were being taken at the same time:

Acetaminphen And Codeine Phosphate (Unk, Unk)

Bupropion Hcl (Unk, Unk)

When using Carbon Monoxide, the patient experienced the following unwanted symptoms/side effects: Completed Suicide, Cardio-respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Completed Suicide, may become evident only after a product is in use by the general population.

Carbon Side Effect Report#7749658-XCardio-respiratory Arrest

This Cardio-respiratory Arrest side effect was reported by a health professional from United States. A 4-year-old patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Carbon Monoxide/smoke (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:

Midazolam Hydrochloride (Unk, Unk)

.After starting to take Carbon Monoxide/smoke the consumer reported adverse symptoms, such as: Cardio-respiratory ArrestThese side effects may potentially be related to Carbon Monoxide/smoke.

This is a report of a 51-year-old patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Carbon Monoxide (dosage: Unk, Unk, start time: NS), combined with:

Fluoxetine (Unk, Unk)

Olanzapine (Unk, Unk)

and developed a serious reaction and side effect(s): Cardio-respiratory Arrest, Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Monoxide treatment in patients, resulting in Cardio-respiratory Arrest side effect.

This report suggests a potential Carbonyl Iron [iron Pentacarbonyl]Migraine side effect(s) that can have serious consequences. A 15-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Carbonyl Iron [iron Pentacarbonyl] (dosage: NA) starting

The patient was hospitalized and became disabled. Although Carbonyl Iron [iron Pentacarbonyl] demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Migraine, may still occur.

This Carbon Monoxide Poisoning problem was reported by a physician from United States. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Carbon Monoxide (no Pref. Name) (dosage: Po). The following drugs were being taken at the same time:

Oxycontin (Po)

When using Carbon Monoxide (no Pref. Name), the patient experienced the following unwanted symptoms/side effects: Carbon Monoxide Poisoning, Cardiac Arrest, Thermal Burn, Respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Carbon Monoxide Poisoning, may become evident only after a product is in use by the general population.

Carbon Side Effect Report#7322430-0Completed Suicide

This Completed Suicide side effect was reported by a health professional from United States. A 81-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Carbon Black (drug dosage: Unk, Unk), which was initiated on NS. Concurrently used drugs:

Acetaminophen (Unk)

.After starting to take Carbon Black the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Carbon Black.

Carbon Side Effect Report#7309066-2Cardio-respiratory Arrest

This is a report of a 27-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Carbon Monoxide (dosage: NA, start time: NS), combined with:

Fentanyl-100

and developed a serious reaction and side effect(s): Cardio-respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Carbon Monoxide treatment in male patients, resulting in Cardio-respiratory Arrest side effect.

The appearance of Carbon on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

You can use them to remind you of details that may alert your health care professional(s) to a problem

You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

Log Form

You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

Medicine Name and Dosage:

Side Effects

Scale

Date & Time

Other Medicine(s) or Treatment(s)

Scale: 1 = very mild to 10 = very bad

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Carbon reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials

[Posted 12/29/2010]

AUDIENCE: Hospital Risk Managers, Pharmacy, Emergency Medicine

ISSUE: American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Sodium Bicarbonate Injection, USP, is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

RECOMMENDATION: Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials with the lot #s list in the firm press release for patient care and should immediately quarantine any product for return.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

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